3 June 2013

MedDRA Management Board Continues to Facilitate Further Global Uptake of MedDRA

La Hulpe, 2 June 2013 – The MedDRA Management Board met in La Hulpe, Belgium on 1 - 2 June 2013.

The MedDRA Management Board welcomed to a special session representatives of Regional Harmonisation Initiatives and of Drug Regulatory Authorities/Departement of Health interested in MedDRA. During this session, presentations included MedDRA as a multi-axial terminology, facilitating the use of MedDRA, and best practices for using the terminology. In addition, a representative of China’s ICH Research M Group – a working group that studies the “M” ICH initiatives – provided an update on their activities.

The Japanese Management Board (JMB) reported on the activities of the Japanese Maintenance Organization (JMO). The JMO has started to provide MedDRA in European languages to their subscribers for no additional fee. The JMB also noted an increase in JMO Web-academia subscribers. It was noted that the JMO expects to receive their ISO certification of the JMO’s MedDRA maintenance processes in June 2013.

The ICH Secretariat reported on a meeting held in March 2013 in Beijing, China. The meeting was attended by members of the China Food and Drug Administration, the Chinese Pharmacopoeia, members of the ICH Research M Group, representatives of the Chinese industry, and ICH representatives. Presentations were given by ICH regulatory authorities regarding the use of MedDRA in their regions. Additional topics included the Chinese translation of MedDRA and the feasibility of implementing MedDRA in China.

The MSSO reported that they trained over 1400 MedDRA users in 2012. This included training sessions hosted by regulatory authorities in Germany, Canada, Turkey and China, and by the European Medicines Agency. The MSSO also posted on their website several new training videocasts that can be freely downloaded or streamed. These videocasts are short presentations on focused topics such as the scope and structure of MedDRA and Standardised MedDRA Queries (SMQs).

The next scheduled meeting of the Board will be on 9 - 10 November 2013 in Osaka, Japan.

For further information, please contact the ICH Secretariat at admin@ich.org.

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